PReventive cOlostomy vs Ileostomy in Low anTErior reCTal Resection

Overview

The type of preventive intestinal stoma (colostomy/ileostomy) after low anterior rectal resection rectum is still a debate. This study purpose is to demonstrate that preventive loop ileostomy is characterized by a higher readmission rate caused by dehydration, in comparison with the loop colostomy.

Full Title of Study: “Multi-center, Randomized, Parallel-group, Superiority Study to Compare Outcomes of Protective Double-Barrelled Colostomy Versus Protective Double-Barrelled Ileostomy in Low Anterior Resection for Rectal Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2, 2020

Detailed Description

Modern surgery for the rectal cancer is featured by sphincter-preserving operations. It is proved that colorectal anastomosis leakage is severe and, in some cases, lethal complication that reduces quality of life of patients and increases the risk of disease reccurence. The presence of preventive stoma is an effective way to avoid this complication that is why it's included to treatment protocols for the middle and low ampullary rectal cancers is undisputed by the most of surgeons. However, the type of preventive stoma is under discussion yet and remains to be an urgent issue. The majority of large meta-analyzes demonstrates that preventive ileostomy is used more often for the protection of low colorectal anastomoses. In the western countries the preferred method is double barreled ileostomy due to more rapid formation and closure, as well as due to lower rate of stoma-related morbidity. In Russia and CIS countries the double-barreled transverse colostomy is a preferred method of defuction of low colorectal anastomosis due to lower rate of electrolytic disorders and related hospital admissions, along with series of unproven advantages. Presented study will allow to reveal the early and late postoperative morbidity rate and the related hospital re-admissions in real-life clinical practice of Russia from the standpoints of evidence- based medicine, to define indications and contraindications for each type of "low" colorectal anastomosis protection with the least risk for the patient.

Interventions

  • Procedure: Low anterior resection with protective loop ileostomy
    • Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning ileostomy is performed.
  • Procedure: Low anterior resection with protective loop transverse colostomy
    • Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning transverse colostomy is performed.

Arms, Groups and Cohorts

  • Active Comparator: Ileostomy
    • Loop protective ileostomy as a defunction mean after low anterior resection with D3 lymphnode dissection
  • Active Comparator: Colostomy
    • Loop protective transverse colostomy as a defunction mean after low anterior resection with D3 lymphnode dissection

Clinical Trial Outcome Measures

Primary Measures

  • The rate of readmissions due to severe dehydratation
    • Time Frame: 6 weeks
    • The percentage of patients who were readmitted to the hospital due to dehydration, that could not be managed in outhospital setting

Secondary Measures

  • Early postoperative complications rate
    • Time Frame: 30 days after the initial procedure
    • The rate of all postoperative complications in early postoperative period after resectional surgery
  • Late postoperative complications rate
    • Time Frame: starting on 31st day and within 6 months in late postoperative period after the initial procedure
    • The rate of all postoperative complications
  • Overall quality of life
    • Time Frame: 6 and 12 months after the initial procedure
    • Assessed with patient-reported questionnaire SF-36. A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability
  • Time with stoma
    • Time Frame: 5 years
    • The period of time between initial resectional procedure and closure of protetctive stoma only in patients who had their intestinal stoma reversed
  • The rate of early postoperative complications after stoma closure operation
    • Time Frame: 3 months after stoma closure
    • The rate of early postoperative complications after stoma closure operation

Participating in This Clinical Trial

Inclusion Criteria

  • Mid- and low rectal cancer – Age ≧ 18 – TME – ASA ≦ 3 – No previous stoma formation – Informed consent for participation Exclusion Criteria:

  • Patients lost during the follow-up – Refusal of the patient from further participation in the study – Inability of stoma formation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Russian Society of Colorectal Surgeons
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Petr Tsarkov, Principal Investigator, Clinic of Colorectal and Minimally Invasive Surgery
    • Inna Tulina, Study Chair, Clinic of Colorectal and Minimally Invasive Surgery

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